On July 31, 2025, the Health Resources and Services Administration (HRSA), Office of Pharmacy Affairs (OPA) issued a 340B Drug Pricing Program notice (the “Notice”) announcing the launch of a voluntary 340B rebate model pilot...more
8/4/2025
/ Centers for Medicare & Medicaid Services (CMS) ,
Comment Period ,
Covered Entities ,
Drug Pricing ,
HRSA ,
Manufacturers ,
Pharmaceutical Industry ,
Pharmacies ,
Pilot Programs ,
Public Comment ,
Rebates ,
Reporting Requirements ,
Section 340B
In a May 15, 2025, opinion, Judge Dabney Friedrich of the US District Court for the District of Columbia denied drugmakers’ motions for summary judgment against the US Department of Health and Human Services and the Health...more
5/30/2025
/ Department of Health and Human Services (HHS) ,
Drug Pricing ,
HRSA ,
Judicial Authority ,
Manufacturers ,
Medicaid ,
Motion for Judgment ,
Pharmaceutical Industry ,
Pre-approval ,
Prescription Drugs ,
Rebates ,
Regulatory Authority ,
Sanofi ,
Section 340B
Welcome to the fifth issue of Health Headlines, a newsletter created by lawyers in our Healthcare practice....more
5/1/2025
/ Congressional Committees ,
Drug Pricing ,
Executive Orders ,
Food and Drug Administration (FDA) ,
Government Agencies ,
Healthcare ,
Healthcare Reform ,
Medicaid ,
Medicare ,
New Legislation ,
Pharmaceutical Industry ,
Pharmacy Benefit Manager (PBM) ,
Proposed Legislation
Welcome to the third issue of Health Headlines, a newsletter created by lawyers in our Healthcare practice....more
3/30/2025
/ Affordable Care Act ,
Annual Reports ,
Caremark claim ,
Centers for Medicare & Medicaid Services (CMS) ,
Criminal Prosecution ,
CVS ,
Drug Pricing ,
Executive Orders ,
Federal Trade Commission (FTC) ,
Healthcare ,
Healthcare Fraud ,
Medicaid ,
Medicare ,
Pharmaceutical Industry ,
Price Transparency ,
Proposed Rules ,
Trump Administration
In February 2025, the Office of Inspector General (OIG) for the US Department of Health and Human Services issued favorable advisory opinions Advisory Opinion 24-10 and Advisory Opinion 24-12, providing additional guidance on...more